LLY - Bristol Myers gets priority review for urothelial cancer combination therapy
2023-12-05 07:30:00 ET
The U.S. Food and Drug Administration has granted Bristol Myers Squibb ( NYSE: BMY ) a priority review for its supplemental biologics license application of a combination therapy for patients with untreated, unresectable or metastatic urothelial carcinoma.
Bristol Myers' ( BMY ) Opdivo (nivolumab) in combination with cisplatin-based chemotherapy is being studied as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
The filing was based on the results from the Phase 3 CheckMate -901 study, in which the combination showed statistically significant and clinically meaningful survival benefit over standard-of-care gemcitabine, sold under the Eli Lilly ( LLY ) brand Gemzar, plus cisplatin in the treatment of this patient population.
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the U.S.
The FDA has set a target action date of April 5, 2024.
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Bristol Myers gets priority review for urothelial cancer combination therapy